Genetically-modified cell therapies are revolutionizing medicine, offering new opportunities to treat cancer patients and potentially many other diseases. The process of producing gene-modified cell therapies, in particular CAR-T cells, derived from patients is very complex, however, restricting widespread use. The current process involves collection of T cells by apheresis, and shipment from the hospital to a centralized manufacturing site, where cells transduced with gene and grown for 2-3 weeks, before returning to the hospital for infusion into the patient. The significant complexity, freeze/thaw cycles, shipments, and delay in getting therapies pose challenges. As an alternative, a point of care cell therapy production within hospitals would obviate the need for shipping and may reduce the time to get therapies to patients. Automated manufacturing machines will be essential in this paradigm, in order to standardize cellular manufacturing across all hospitals and to deliver the same products to patients. A distributed point-of-care paradigm may ultimately provide an avenue to scale cell therapies to more patients and expand into new clinical indications.
1. Define the mechanism of cell therapies and their clinical indications
2. Identify the key bottlenecks in the delivery of cell therapies to patients today
3. Explain how point of care cell therapy production in hospitals could work